NCT01555944

Brief Summary

This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium. Principal objectives:

  1. 1.To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged \> or = 65 years
  2. 2.To observe the management of cardiovascular risk during and after anthracycline treatment
  3. 3.To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30)
  4. 4.To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams)
  5. 5.To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment.
  6. 6.To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups
  7. 7.To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline
  8. 8.To calculate the cardiovascular risk according to SCORE

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

4.2 years

First QC Date

March 14, 2012

Last Update Submit

April 22, 2016

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • cardiovascular risk factors

    15 months

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Belgian women aged \> or = 65 years with metastatic breast cancer before and after anthracycline treatment. Patients will be included in 24 centers specialized in the treatment of breast cancer, in Belgium.

You may qualify if:

  • women aged 65 years old or more
  • with confirmed metastatic breast cancer (MBC)
  • who will be treated with anthracyclines in first or second line
  • who have a Karnofsky score at baseline of 50
  • who agree and are able to fill in the EORTC QLQ-C30 questionnaire
  • who gave their informed consent

You may not qualify if:

  • women having contra-Indications for anthracyclines
  • women aged \< 65 years old
  • with no metastatic breast cancer
  • who will not be eligible for an anthracycline treatment in first or second line MBC
  • who have a Karnofsky less than 50
  • who disagree or are unable to fill in the EORTC QLQ-C30 questionnaire
  • women refusing or not having signed their informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Cliniques du Sud Lux - St Joseph

Arlon, 6700, Belgium

Location

Imelda

Bonheiden, 2820, Belgium

Location

Clinique Saint-Luc

Bouge, 5004, Belgium

Location

AZ KLINA

Brasschaat, 2930, Belgium

Location

AZ St Jan

Bruges, 8000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

Erasme

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

CHIREC - Centre Hospitalier Interrégional Edith Cavell

Brussels, 1180, Belgium

Location

CSF

Chimay, 6460, Belgium

Location

AZ St-Maarten

Duffel, 2570, Belgium

Location

UZA

Edegem, 2650, Belgium

Location

AZ St-Dimpna

Geel, 2440, Belgium

Location

AZ St-Lucas

Ghent, 9000, Belgium

Location

ZNA Jan Palfijn

Merksem, 2170, Belgium

Location

CHR

Namur, 5000, Belgium

Location

CMSE

Namur, 5000, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

Clinique St Pierre

Ottignies, 1340, Belgium

Location

AZ Nikolaas

St-Niklaas, 9100, Belgium

Location

Centre Hospitalier de Wallonie picarde - site IMC

Tournai, 7500, Belgium

Location

CHPLT

Verviers, 4800, Belgium

Location

CHU Mont-Godinne

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christel Fontaine, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 16, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 25, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(24)